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MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting

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ClinicalTrials.gov Identifier: NCT03728244
Recruitment Status : Unknown
Verified October 2018 by Ahmed Mohamed Ahmed Hassan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Ahmed Hassan, Cairo University

Tracking Information
First Submitted Date  ICMJE October 27, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Post operative pain: VAS [ Time Frame: on day 7 ]
measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Color match [ Time Frame: On day 42 ]
    of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.
  • wound size [ Time Frame: at day 21 ]
    To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting
Official Title  ICMJE Clinical Comparison of MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting: A Randomized Clinical Trial
Brief Summary

Postoperative pain as well as bleeding are the most common complications after palatal graft harvesting also postsurgical swelling have been reported , Although different agents were used to protect the denuded areas on the palate as gelatin sponge , platelet rich fibrin (PRF) , medicinal plant extract (MPE) and platelet concentrate , no gold standard can be specified for this purpose

PICO Format:

P: Patients with mucogingival defects that require free gingival graft. I:1. Hyaluronic acid gel 0.2% placed in the palatal donor site then covered with periodontal pack (test group I) 2.MEBO ointment placed in the palatal donor site then covered with periodontal pack (test group II) C: Periodontal pack only O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative.

Aim of the study:

To compare the effect of MEBO ointment versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.

Research question:

Is MEBO ointment as effective as hyaluronic acid gel in the management of postoperative pain after free gingival graft harvesting in the management of mucogingival defects?

Detailed Description

Interventions:

  1. Hyaluronic acid gel 0.2%
  2. MEBO ointment

Procedure:

The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.

The graft will then be used as it on the recipient bed.

The graft dimensions will be recorded (width and length).

Denuded palatal area will then be protected using one of the following options:

  1. Periodontal pack only (control group)
  2. HA gel 0.2% covered with a periodontal pack (test group I)
  3. MEBO ointment covered with a periodontal pack (test group II)

Postoperative instructions:

Postoperative instructions will include discontinuing toothbrushing and flossing around the surgical sites until the day of periodontal dressing removal (day 7).

Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma.

Patients will be scheduled to be seen on days 3, 7, 14, 21 and 42.

Periodontal pack will be first removed on day 3, and donor sites will be evaluated using selected parameters in both groups.

After evaluation, HA gels together with periodontal pack will be reapplied in test group I, MEBO ointment with periodontal pack will be reapplied in test group II whereas periodontal pack only will be reapplied in control group

On day 7, the periodontal packs will be removed for reevaluation of the wound area in all groups. Thereafter, all patients will be followed up on days 14, 21 and 42 for further evaluation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft Pain
  • Gingival Recession
Intervention  ICMJE
  • Drug: MEBO ointment
    The pharmacological effects of MEBO are attributable to beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensi, Beeswax and sesame oil (Zhang et al., 2005).
    Other Name: beta-sitosterol
  • Drug: Hyaluronic Acid gel
    Hyaluronic acid is a substance that is naturally present in the human body. It is found in the highest concentrations in fluids in the eyes and joints. The hyaluronic acid that is used as medicine is extracted from rooster combs or made by bacteria in the laboratory.
    Other Name: gengigel
Study Arms  ICMJE
  • Experimental: test group Hyaluronic acid
    Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%
    Intervention: Drug: Hyaluronic Acid gel
  • Experimental: test group MEBO ointment
    Patients scheduled for free gingival graft harvesting will receive MEBO ointment
    Intervention: Drug: MEBO ointment
  • No Intervention: negative control group
    Patients scheduled for free gingival graft harvesting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with mucogingival defects scheduled for free gingival graft
  • Systemically healthy

Exclusion Criteria:

  • Smokers
  • Occlusal trauma at site of graft
  • Pregnancy and lactation
  • Patients allergic to the used agents
  • Severe gagging reflex
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728244
Other Study ID Numbers  ICMJE 170992
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed Mohamed Ahmed Hassan, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP